0 Evaluaciones
ID

33521

Descripción

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria

Palabras clave

Versiones (4)
  1. 11/12/18 11/12/18 -
  2. 6/6/19 6/6/19 -
  3. 12/6/19 12/6/19 -
  4. 27/9/21 27/9/21 -
Titular de derechos de autor

GSK group of companies

Subido en

11 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

    Inglés

    Visit 2: Laboratory Tests - Serology

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Protocol Number
    Descripción

    Protocol Number

    Tipo de datos

    integer

    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    integer

    Visit
    Descripción

    Visit

    Tipo de datos

    text

    Blood Sample for Antibodies to CS
    Descripción

    Blood Sample for Antibodies to CS

    Has a blood sample been taken for antibodies to CS?
    Descripción

    For Cohort 2 only from Malaria-026

    Tipo de datos

    boolean

    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Blood Sample for Antibodies to HBs
    Descripción

    Blood Sample for Antibodies to HBs

    Has a blood sample been taken for antibodies to HBs?
    Descripción

    For Cohort 2 only from Malaria-026

    Tipo de datos

    text

    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Blood Sample for Hematocrit
    Descripción

    Blood Sample for Hematocrit

    Has a blood sample been taken for hematocrit?
    Descripción

    Has a blood sample been taken for hematocrit?

    Tipo de datos

    boolean

    Date sample taken
    Descripción

    Date sample taken

    Tipo de datos

    date

    Test
    Descripción

    Test

    PCV (Packed cell volume) / Hematocrit
    Descripción

    PCV (Packed cell volume) / Hematocrit

    Tipo de datos

    text

    Results
    Descripción

    Results

    Tipo de datos

    float

    Unidades de medida
    • %
    %
    Out of range values
    Descripción

    Out of range values

    Tipo de datos

    integer

    If Other, please specify
    Descripción

    If Other, please specify

    Tipo de datos

    text

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    Similar models

    Visit 2: Laboratory Tests - Serology

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    Protocol Number
    Item
    Protocol Number
    integer
    Subject Number
    Item
    Subject Number
    integer
    Item
    Visit
    text
    Visit
    Code List
    Visit
    CL Item
    Visit 2, Study month 33 (33 months post dose 1 in Malaria-026, 12 months after visit 1) (1)
    Item Group
    Blood Sample for Antibodies to CS
    Has a blood sample been taken for antibodies to CS?
    Item
    Has a blood sample been taken for antibodies to CS?
    boolean
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Blood Sample for Antibodies to HBs
    Item
    Has a blood sample been taken for antibodies to HBs?
    text
    Has a blood sample been taken for antibodies to HBs?
    Code List
    Has a blood sample been taken for antibodies to HBs?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (for Cohort 1) (3)
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Blood Sample for Hematocrit
    Has a blood sample been taken for hematocrit?
    Item
    Has a blood sample been taken for hematocrit?
    boolean
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Test
    Item
    PCV (Packed cell volume) / Hematocrit
    text
    PCV (Packed cell volume) / Hematocrit
    Code List
    PCV (Packed cell volume) / Hematocrit
    CL Item
    Done (1)
    CL Item
    Not done (2)
    Results
    Item
    Results
    float
    Item
    Out of range values
    integer
    Out of range values
    Code List
    Out of range values
    CL Item
    Laboratory error (1)
    CL Item
    Preexisting/concomitant medical condition, please specify in table above (2)
    CL Item
    Prior/Concomitant Medication (3)
    CL Item
    Child is well - not investigated further (4)
    CL Item
    Other (5)
    If Other, please specify
    Item
    If Other, please specify
    text
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